UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048595 |
|---|---|
| Receipt number | R000055341 |
| Scientific Title | Risk Factors of Poor Arousal After Sedated Endoscopy. |
| Date of disclosure of the study information | 2022/08/10 |
| Last modified on | 2024/02/04 09:04:37 |
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Basic information
Public title
Risk Factors of Poor Arousal After Sedated Endoscopy.
Acronym
Risk Factors of Poor Arousal After Sedated Endoscopy.
Scientific Title
Risk Factors of Poor Arousal After Sedated Endoscopy.
Scientific Title:Acronym
Risk Factors of Poor Arousal After Sedated Endoscopy.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the effects of 5 clinical factors: (1) age, (2) sex, (3) type of examination, (4) use of pethidine, and (5) Richmond Agitation-Sedation Scale (RASS) at the end of the examination on the prolonged time to release from rest after sedated endoscopy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resting time after sedated endoscopy.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent upper and lower gastrointestinal endoscopy with benzodiazepine sedation in our hospital from March to the end of May 2020.
Key exclusion criteria
1. Patients who used antagonists, had upper and lower endoscopy performed on the same day, and had missing data.
2. Patients who have requested not to opt-out of the use of their data.
3. Patients who are judged to be inappropriate as subjects for this study by the principal investigator or subinvestigator of the clinical research.
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Miyachi |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasaki-chuo, Tsudukiku, Yokohama City, Kanagawa
TEL
045-949-7000
to.skyline0514@gmail.com
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Semba |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasaki-chuo, Tsudukiku, Yokohama City, Kanagawa
TEL
045-949-7000
Homepage URL
to.skyline0514@gmail.com
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Showa University Northern Yokohama Hospital
Address
35-1 Chigasaki-chuo, Tsudukiku, Yokohama City, Kanagawa
Tel
045-949-7000
semba@med.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1472
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055341
